ES2354033T3 - DEVICE FOR THE GENERATION OF A PULSED ELECTROMAGNETIC FIELD WITH PULSE CONTROL. - Google Patents

Abstract

Device for generating a pulsed electromagnetic field with pulse control, comprising a pulse generator connected to a coil to generate an electromagnetic field, representing the pulses that start from the periodic pulse pulse generator that have upward and downward envelope curves with development of harmonic or non-harmonic oscillations within the envelope curves; the pulse sequence is of the order of 1 pulse / 20 minutes up to 4 pulses / 1 minute and the pulse intensity is of the order of 5-300 µT and the pulse sequence command, of the pulse width, the type of Pulse and flow density function is based on measurement data that reproduce the characteristics of the microcirculation of blood from a target tissue by means of vital microscopic, spectrometric, laser-Doppler, or partial pressure non-invasive measurement procedures. oxygen, in which the functional type does not include those impulses with exponential functions.

Description

Device for generating a field Pulsed electromagnetic with pulse control.

The invention relates to a device for generate a pulsed electromagnetic field with pulse control.

A device is known from EP 0 594 655 B1 consisting of a generator and an emitter, with which it must be carried out a transport of intracorporeal fluid and electrolyte ions in and through the vascular walls and in which the currents applied pulses have certain characteristics, particularly the amplitude of the basic impulses correspond to a function e and a sequential series of pulses is sent to 0.3-1 seconds with pauses of 0.7-5 seconds.

EP 0 995 463 B1 claims a device to influence biological processes in a living tissue, in which pulses are emitted to the tissue, in which the amplitude of each individual impulse corresponds to a mathematical relationship with the function e e ^ {sin (x \ high \ b)} in which x is the time course and b is the number of overlapping impulses.

The signal forms generated with the known devices, which always correspond to functions e, well they should improve muscle formation and regeneration of joints or stimulate metabolic processes.

From Rosenspire et al ., Biophys. I. Vol 88, May 2005, pages 3334-3347 the influence of poorly pulsed magnetic fields on the oscillation of NAD (P) H, the redox potential of flavoprotein and the reduction of ROS and NO in neutrophils is known.

JP 03-277381 describes the Vasomotion adaptation by modification of the electrical voltage or the frequency of a low frequency pulse by modification of a capacitor voltage. The invention is based on the mission of provide a device, with which others can be improved characteristics of bodily functions by certain impulses of a pulsed magnetic field.

According to the invention, a device to generate a pulsed electromagnetic field with command pulse, which comprises a pulse generator connected to a coil to generate an electromagnetic field, in which the pulses that start from the pulse generator represent pulses newspapers presenting curves of ascending envelopes and descending with a development of harmonic oscillations or not harmonics within the envelope curves, being the sequence of impulses of the order of 1 impulse for 20 minutes up to 4 impulses per minute and the impulse sequence command, the width of impulses, the type of impulse function and the flow density Electromagnetic is based on measurement data that reproduce characteristics of blood microcirculation from a target tissue through non-invasive measurement procedures, vital microscopic, spectrometric or measurement procedures by laser, Doppler or partial pressure oxygen, in which the type of function does not include impulses with functions exponential

It was considered that impulses with functions e and at the described frequency of the pulse sequence of maximum 5 seconds or a pause of maximum 3 seconds by the way impact to some extent in some features of the functional state of microcirculation both in the healthy person and in the case of illness, however only with an influence brief and limited mechanisms of local regulation of microcirculation, so that therefore they cannot be caused relevant prophylactic and therapeutic variations.

It has also been considered that in the case of a total apparent deceleration of the pulse sequence and in pulses with non-ascending and descending envelope curves exponentially some modifications of features considerably and clearly bigger and also constants of the functional state of the microcirculation because of a more intense direct influence of the mechanisms of local regulation of microcirculation.

The microcirculation, the flow of cells blood and blood plasma in smaller blood vessels (with diameters of <200 µm) is the most functional part important of the circulation of human blood, since here the substance exchange is done with the cells of a tissue of organ. This affects the transport of oxygen and substrate to the cells and the evacuation of end products of metabolism. He respective functional state of the microcirculation of an organ determines the width of regulation for an adaptation of the microperfusion to varying metabolism needs and by consequently the function of the organ. In addition, a microcirculation Quiet is the condition for a free development of the first steps of an immune reaction. Because of that, the microcirculation has already advanced for some time to the center of pathophysiological clinical investigations. Of a particular interest is here the investigation of possible influences of local regulation of microcirculation, particularly of the authoritative contractive movements of the smooth vascular wall musculature in arteriolar microvessels and venular (the so-called vasomotion).

To the most important criteria for characterization of a normal or disturbed microcirculation belong

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he respective state of distribution of blood in the networks of microvessels;

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the Authoritic (spontaneous) movements of the vascular wall in arterioles and venules (vasomotion);

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he current flow in the arteriolar inflow and venular outflow of hair nets;

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rheological characteristics (hematocrit local);

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cell flow rates blood

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diameter of the microvessels;

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possibility of enrichment of white blood cells in the area of microcirculation, endothelial adhesions and blood cell transmigrations White in the tissue.

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The functional state of vasomotion determines essentially the adaptation width of the microcirculation to the metabolism needs that vary and therefore the width of local regulation of microcirculation.

According to the invention, the blood microcirculation measurement data for the command of pulses of an electromagnetic field. This measurement data are selected from the group consisting of oxygen depletion on the side of venules, the number of nodal perfusion points of blood cells, venular current flow, hematocrit local in a microvase, the local hematocrit in all microvessels, spontaneous arteriolar vasomotion, vasomotion status venular, the number of adherent white blood cells in a interior wall of venules defined, local modifications of concentration of substances in the tissue. It is advantageous to resort to Several of these features.

Depletion of oxygen on the side of venules Δp2 is indicated as a percentage change in comparison with the respective initial value at time t = 0. The absolute difference in hemoglobin oxygen saturation in the affluent arterioles and outgoing venules of the tissue network selected goal. As a goal, tissue sections of the skin or intestine that have vessel networks desired blood of the organism and which also belong to the immunologically active organs that are also easily accessible for non-invasive measurements.

With the number of nodal perfusion points of blood cells in the defined microvascular network, nNP, is uses the number of perfusion branching sites of blood cells in this network as a measure for the state of blood distribution As limit speed of cells Red blood is defined V_ {RBC} = 80 µm / s. The evaluation is performed at + or - (compared to the defined initial value n = 60). The Limit cases are assessed with +0.5 or -0.5.

The flow of ventricular current Qven and the flow of Qart arteriolar current is the flow of particles (flow of blood cells) in defined venules or arterioles. He himself indicates in \ mum3 / s.

The local hematocrit in a blood vessel, which It is also called tube hematocrit, Hk_ {t}, it is the hematocrit in a given microvass. That is indicated as percentage change compared to the initial value.

The hematocrit of the microcirculation Hk_ {MC} It is measured in all microvessels with diameters of <200 \ mum.

The state of arteriolar (or venular) vasomotion, A_ {VM}, it is determined by determining the route diagram and time of the authoritative contractive movements of the cells muscular muscles of the arteriolar vascular wall (measurement of normal distance to the longitudinal axis of the surface microvase endothelial to the opposite endothelial surface at times of equidistant measurement; per second 60 measured values; detection of the compound swing; FOURIER analysis; spectrum detection of amplitudes and frequency). The criterion is surface A under the envelope of the spectrum of amplitudes and frequency of vasomotion arteriolar (a composite oscillation). The value is indicated as percentage variation compared to the initial values.

The number of white blood cells adherent in a defined inner wall of venules, nWBC / A, se measured on the defined inner surface of the venules with A = 18000 um2. All white blood cells are counted, which adhere more than 20 seconds to the endothelium.

Local modifications of the concentration of different substances in the tissue are measures p. ex. for mediators, the adhesion molecule ICAM-1 and others. Those are indicated in relative units, of 0-10, in which 0 does not mean any test and the value 10 is associated with the highest value detected in a sample taken at random.

The basis for measuring these characteristics in human tissue is described p. ex. in Bollinger et al ., Microvasc Res 7 (1974) 61-72; Fagrell B, Angiology 23 (1972) 284-298; Fagrell et al ., Am J Physiol 233 (1977) H318-321; Wiedemann et al ., An introduction to microcirculation, Academic Press, NY 1981; and Lankowicz JR (Ed.): Topics in Fluorescence Spectroscopy, Plenum Press, New York, London, Vol. 1-5 (1991-1997), to which reference is made in the present case .

For all enhanced measurement data, it uses a control procedure without parameter for small samples taken at random. The WILCOXON test is applied for independent samples at the significant level α = 5%. The Critical values for T are taken from the literature (Ferguson G, Statistical analysis in psychology and education psychology and education statistics), McGraw-Hill, NY 1959, 318).

Of particular importance is vasomotion. Prophylactic and therapeutically relevant is an influence of disturbed vasomotion towards a physiological vasomotor rhythm, is that is, the "marking" of a physiological vasomotor rhythm in the case of illness. In the case of disease the movements vasomotors of arteriolar and venular microvessels are considerably modified (in most cases clearly slowed down; sometimes only less than 1 to 2 vasomotor movements in the course of several minutes). According to the invention it is desired carry disturbed vasomotion at the margin of vasomotion physiological (approx. 1-10, particularly 1-4 vasomotor movements per minute). The corresponding applies to pathological conditions with a vasomotion considerably accelerated.

It was therefore considered that, in addition to the effects of certain pulsed electromagnetic fields described, it can be achieved in the fabric especially a change of pace of the disturbed spontaneous arteriolar vasomotion, usually in the sense of a stimulation of the contractive movements authoritics of the flat vascular wall musculature in the smaller blood vessels (vasomotion of arterioles and venules). In clear modifications of the pulse sequence (slowdown of the sequence of impulses with respect to the procedures known) and in pulses with non-ascending envelope curves and / or exponentially or abruptly descending descending can be caused considerably larger modifications of characteristics of blood microcirculation.

In an obvious deviation from methods known, in which case the tension, respiratory rate or heart rate (macrocirculation) for a magnetic field treatment, that is particularly during the treatment itself, the special values of the microcirculation cited above particularly measured already before treatment they are taken by base with the device of the invention for treatment with extremely frequent frequencies reduced

Therefore they are preferably generated by the device according to the invention the pulse sequences that are they are in the range of 1 pulse / 10 minutes at 2 impulses / 1 minute, preferably 1 pulse / 5 minutes at 3 pulses / 1 minute, particularly 1 pulse / 2 minutes to 1 pulse / 1 minute. In Fig. 4a and 4b, said advantageous pulse sequences are represented in an exemplary manner without reference to the intensity.

Under "pulse sequence" in the sense from the present invention the distance of said values is understood oscillation maxima (the maximum impulses) of each other, which are above the zero intensity line in a diagram of intensity-time as represented p. ex. in Fig. 4c. If there is a basic swing, which can be invariable in terms of intensity, stochastically different or different in sinusoidal form, as shown in Fig. 4d or 4e or 4f, "pulse sequence" means the distance of said oscillation maxima of each other which is found clearly above the basic swing.

The sequence of impulses is therefore the frequency of the presence of maximum amounts of the curve of wrap in time unit.

So for example there can be a swing basic continuous of an intensity of 80 µT with a width of impulses of approx. 30 \ mus and an individual impulse clearly more intense of 150 µT with a pulse width greater than 0.3 s, appearing the most intense individual impulse three to five times by minute. This then corresponds equally to the sequence of impulses in the sense of the invention.

One such arrangement of impulses can be advantageous, that is, add to the impulse mentioned above or to the pulse sequence mentioned above (Fig. 4a and 4b) an impulse of higher frequency with an electromagnetic flow density B. These additional impulses may vary differently in their amplitudes (and frequencies), as represented in a manner exemplary in Figs. 4c to 4h. Those are usually in the order of 50 to 80 µT.

Advantageously the width of an impulse individual is in 50 to 300 ms and the width of an impulse basic in 10 to 60 ms; Preferred are 80 to 200 ms or 20 to 40 ms.

The referred "intensity" or intensity of impulse is physically the electromagnetic flux density B with the Tesla unit.

The impulses generated by the device according to the invention are issued periodically and represented on a graph in its envelope curves some constructivist theories in form arc such as sinusoidal, cosine even similar to a parable. Within the envelope curves are have harmonic oscillations with the same or different amplitude, which can also overlap in non-harmonic oscillations. Low "wrap curve" means that curve that affects the maximum of different amplitudes of a given sequence of amplitudes and "wraps" so this sequence in the part ascending and descending (see Fig. 2). In oscillations no overlapping harmonics this always refers only to the maximum of the next highest amplitude.

The impulses therefore correspond preferably to a type of function, whose rise and fall of envelope curves develop approximately arched as in rectified currents.

The impulses are oscillations or composite waves that are formed from a multitude of partial oscillations as harmonics or non-harmonics of different amplitudes and frequency, the partial frequencies being between? 20 and 3000 Hz.

The "envelope curve" joins the different amplitudes of partial oscillations (amplitude = maximum elongation of a partial oscillation). The "envelope curve" it roughly reflects the development of the oscillation or wave compound.

Particularly preferred is a type of function of the impulse for the envelope curve corresponding to the type of a stream of rectified cosine. One such cosine stream rectified is called in the development of a serial representation According to FOURIER of periodic functions as follows:

one

In a graphic representation it corresponds to the Fig. 1c.

Under "development of a curve in the form of arc "means the development of curves that has no points inflection and is negatively curved, as shown by exemplary manner in Figs. 1a, 1b and 1c.

Examples for oscillation overlap harmonics and the non harmonic oscillation that arises in this case are indicated in Fig. 4.

Optimal treatment results are achieved, when the signal (pulse) varies correspondingly on the basis of functional characteristics of the microcirculation measured simultaneously. In this case the amplitudes can be modified and frequencies of individual impulses, inflection points, of the sequences of impulses or pauses of impulses or intensities. The intensities of the Nanotesla range to the Militesla range are possible, p. ex. 50 nT up to 800 mT, usually however they are Microtesla range with approx. 5-300 µT.

Very good effect measurement results biological regarding vasomotion and the functional state of the microcirculation were obtained in case of densities utilization of electromagnetic flux in the range of approx. 50 µT to approx. 250 µT, preferably from 80 µT to 150 µT. These are Always average means.

For the desired effects in the margin of the microcirculation, a variation of flow densities electromagnetic compared to a variation of the types of impulse and especially the sequence of impulses is smaller importance.

The device according to the invention can be used in healthy people in the sense of an increase in performance or in people exposed to infections and / or stress, in older people with limited body capacity and immune defense reduced and also in the case of illness. Also the treatment of mammals falls under the scope of the invention. For an application prophylactic effects on the vasomotion (characteristic A_ {VM}) and the distribution status of blood in microvascular networks (nNP characteristic) and so both for increased body performance and the best functioning of the organs as a consequence an extension of the microcirculatory regulation width.

Compared to devices, in which the impulses that follow the functions e, and sequences of higher impulses (more frequent appearance of impulses in the unit of time), feature modifications are achieved clearly larger and essentially constant state Functional microcirculation with the device according to the invention.

When for example on impulses with functions e a change of characteristic A_ {VM} of maximum 10% is achieved and produces a decrease in change after approx. 20 minutes, the signal according to the invention shows a maximum of approx. 22%, there is a determined period only slightly descending to this level and Decrease first slowly with approx. 50 to 60 minutes In total it It achieves a clearly improved overall effect.

Advantageous is a job (complementary therapeutic) of the device according to the invention in different diseases, such as p. ex. alterations of the circulation of the peripheral blood, diabetic microangiopathy, polyneuropathy diabetes, alterations of wound healing and healing of bones as well as ulcerations (such as in the case of Ulcus cruris within the framework of chronic venous insufficiency), in multi-morbid and other geriatric patients.

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The invention must be described below. more in detail by examples. In the drawings belonging to show:

Fig. 1 arc pulse with ascent steep and steep descent;

Fig. 1b arch-shaped pulse with ascent plane and plane descent;

Fig. 1c type of cosine current pulse rectified;

Fig. 2 wrap curve (drawn line) of a wave of modified amplitudes;

Fig. 3 superposition of three oscillations harmonics U1, U2 and U3 of the same amplitude and phase and the frequency ratio \ omega_ {1}, \ omega_ {2} and ome3 = 1: 2: 3;

Fig. 4 pulse sequence preferred 2 by 1 minute;

Fig. 4b 1 by 3 pulse sequence minutes;

Fig. 4c diagram of intensity-time with a sequence of pulses 3 per minute (150 ms and 163 µT) with basic pulses in one shorter sequence and with a lower intensity (30 ms and 78 µT);

Fig. 4d extract of a pulse sequence 1 pulse per minute (150 ms and 163 µT) with basic pulses (30 ms and 78 µT) continuously;

Fig. 4e extract of a pulse sequence 1 impulse per minute with basic impulses in an intensity process stochastic and

Fig. 4f extract of a pulse sequence 1 impulse per minute with basic impulses in an intensity process sine.

In the figures, the pulse widths that are of the order of milliseconds, they are not represented to scale.

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Example 1

In a series of people examined with Peripheral blood circulation disorders are measured the representative characteristics of the functional state of the microcirculation through a microscopic research unit vital, through reflection spectroscopy, a measurement of Laser microflow and white light spectroscopy: the number of the nodal points of perfusion of blood cells in a network nNP defined microvascular, vasomotion / arteriolar surface under the envelopes of the spectrum of amplitudes-frequencies of arteriolar vasomotion A_ {VM}.

Then the use of a generator of impulses, with which impulses are generated that lead to a electromagnetic coil The coil is in contact with a skin surface (target tissue). Through this device you emit pulses to the target tissue at a distance of 1 day, 3 days, 6 days, 9 days and 12 days. The measurement of the parameters mentioned above it was performed respectively 10 minutes after completion of The emission of impulses.

Number of people examined: 16.

Age: 55-65 years

Sequence of impulses: 5 per minute.

Pulse Type: rectified approximately in sinusoidal form.

Intensity of pulses: individual pulse with? 180 and a pulse width 150 ms; additionally the basic pulse with µT 60 and of a pulse width of 30 ms.

Duration of treatment: 2 x 25 minutes at an interval of 2 h.

Sequence of treatments: every 2nd day.

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The statistical evaluation was carried out with the WILCOXON test for independent samples, α = 5%.

The percentage change for A_ {VM} was already rising the 3rd day at approx. 11% and increased the 12th day to approx. 22%

The percentage change for nNP already amounted to 3rd day at approx. 10% and increased the 12th day to approx. 24%

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Comparative example one

The procedure was the same as in example 1 with a group of 16 people examined.

Sequence of impulses: 30 per second.

Pulse Type: special exponential function e ^ {sin (x \ high \ 3)} according to EP 995463.

Intensity of pulses: 50 µT with 30 ms pulse width.

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The statistical evaluation was carried out with the WILCOXON test for independent samples, α = 5%.

The percentage change for A_ {VM} amounted to 3rd day at approx. 3% and increased the 12th day to approx. 4%.

The percentage change for nNP amounted to 3rd day at approx. 4% and increased the 12th day to approx. 6%

These modifications do not represent relevant therapeutic modifications and show that both the type of impulse as well as the sequence of impulses does not entail a essential influence of the local regulation mechanism of the microcirculation

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Example 2

In a series of people examined with diabetic microangiopathy proceeded in the same way as in the Example 1.

Number of people examined: 14.

Age: 60-70 years

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The statistical evaluation was carried out with the WILCOXON test for independent samples, α = 5%.

The percentage change for A_ {VM} was already rising the 3rd day to more than 9% and increased the 12th day to approx. 25%

The percentage change for nNP already amounted to 3rd day at approx. 12% and increased the 12th day to approx. 30%

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Comparative example 2

The procedure was the same as in example 2 with a group of 14 people examined. The statistical evaluation is performed with the WILCOXON test for independent samples, α = 5%.

The percentage change for A_ {VM} amounted to 3rd day at approx. 5% and increased the 12th day to approx. 8%

The percentage change for nNP amounted to 3rd day also at approx. 5% and increased the 12th day of approx. 7%

These modifications do not represent relevant therapeutic modifications and show that both the type of impulse as well as the sequence of impulses does not entail a essential influence of the local regulation mechanism of the microcirculation

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Example 3

In a series of healthy older people examined proceeded in the same way as in example 1.

Number of people examined: 16.

Age: 55-65 years, without pathological diagnosis.

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The statistical evaluation was carried out with the WILCOXON test for independent samples, α = 5%.

The percentage change for A_ {VM} was already rising the 3rd day at approx. 7% and increased the 12th day to approx. 12%

The percentage change for nNP already amounted to 3rd day at approx. 8% and increased the 12th day to approx. 16%

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Comparative example 3

The procedure was the same as in example 3 with a group of 16 people examined.

The statistical evaluation was carried out with the WILCOXON test for independent samples, α = 5%.

The percentage change for A_ {VM} amounted to 3rd day at approx. 4% and increased the 12th day to approx. 5%.

The percentage change for nNP amounted to 3rd day at approx. 5% and increased the 12th day to approx. 6%

These modifications show that in applications of both this type of impulse and the pulse sequence entails only a small influence of the functional state of the microcirculation compared to the application of the device according to the invention. The values in the example 3 at the end of the analysis period show contrary a double to triple increase.

The percentage change for A_ {VM} was already rising the 3rd day at approx. 7% and increased the 12th day to approx. 12%

The percentage change for nNP already amounted to 3rd day at approx. 8% and increased the 12th day to approx. 16%

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Documents cited in the description

This list of related documents by the applicant has been collected exclusively for information of the reader and is not part of the European patent document. The it has been made with the greatest diligence; the EPO without However, it assumes no responsibility for any errors or omissions

Related patent documents in the description

EP 0594655 B1 [0002]

JP 3277381 A [0006]

EP 0995463 B1 [0003]

EP 995463 A [0055]

Non-patent related bibliography in the description

Rosenspire et al. Biophys I. , 2005 , Vol. 88, 3334-3347 [0005]

Bollinger et al. Microvasc Res 1974 , 1974, Vol. 7, 61-72 [0022]

Fagrell B. Angiology 1972 , 1972, Vol. 23, 284-298 [0022]

Fagrell et al . Al J 1977 Physiol , 1977 , Vol. 233, 318-321 [0022]

Wiedemann et al . An introduction to microcirculation Academic Press 1981 . [0022]

Topics in Fluorescence Spectroscopy Plenum Press 1991 . vol. 1-5; [0022]

Ferguson G. Statistical analysis in psychology and education McGraw-Hill 1959 . 318- [0023]

Claims (8)

1. Device for generating a field pulsed electromagnetic pulse control, comprising a pulse generator connected to a coil to generate a field electromagnetic, representing the impulses that start from periodic impulse generator that presents curves of envelope ascending and descending with oscillation development harmonic or non-harmonic within envelope curves; the pulse sequence is of the order of 1 pulse / 20 minutes up to 4 pulses / 1 minute and the intensity of pulse is of the order of 5-300 µT and the impulse sequence command of the pulse width, the type of impulse and density function flow is based on measurement data that reproduce the characteristics of the blood microcirculation from a target tissue through non-invasive measurement procedures vital microscopic, spectrometric, by laser-Doppler or partial pressure of oxygen, in which the functional type does not include those impulses with exponential functions.

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2. Device according to claim 1, characterized in that the pulses correspond to a type of function, whose rise and fall of the envelope curves is developed in the form of an arc. 3. Device according to claim 2, characterized in that the type of pulse function for the envelope curve corresponds to the type of a rectified cosine current. Device according to claim 1, characterized in that the pulse sequence is of the order of 1 pulse / 5 minutes to 3 pulses / 1 minute, preferably 1 pulse / 2 minutes to 1 pulse / 1 minute. Device according to claim 1, characterized in that the pulse control is based on blood microcirculation measurement data, which are selected from the group consisting of oxygen depletion of the venular side, the number of points blood cell perfusion nodes, venular current flow, local hematocrit in a microvase, local hematocrit in all microvessels, the state of spontaneous arteriolar vasomotion, the number of adherent white blood cells in a defined inner wall of venules, local modifications of the concentration of substances in the tissue and of several of these characteristics. Device according to claim 4, characterized in that the pulse control is based on the measurement data for oxygen depletion of the venular side. 7. Device according to claim 4, characterized in that the impulse control is based on the measurement data for the state of spontaneous arteriolar vasomotion. Device according to claim 1, characterized in that the pulse intensity is of the order of 5 to 250 µT, preferably 50 to 250 µT, particularly 80 to 150 µT.